NCT06382337

Brief Summary

The aim of the study will be to evaluate maxillary anterior teeth replacement with immediate dental implant utilizing vestibular socket therapy versus ice cream cone technique both clinically and radiographically.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 10, 2024

Completed
11 days until next milestone

Study Start

First participant enrolled

April 21, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 24, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 24, 2024

Status Verified

March 1, 2024

Enrollment Period

10 months

First QC Date

April 10, 2024

Last Update Submit

April 21, 2024

Conditions

Keywords

VSTimmediate dental implantsice cream cone techniqueType 2 socket

Outcome Measures

Primary Outcomes (1)

  • Bone changes

    bone changes in volume by cone-beam computed tomography (CBCT )radiographically .

    12 months

Secondary Outcomes (1)

  • soft tissue changes

    12 months

Study Arms (2)

Group A :immediate dental Implants cases with ice-cream cone technique in type 2 socket

EXPERIMENTAL

immediately placed implants in which the socket defect will be treated utilizing ice cream cone technique by Dennis Tarnow using collagen membrane , allograft bone graft and custom healing abutments

Other: Group A : ice cream cone technique

Group B : immediate dental Implants cases with the vestibular socket therapy in type 2 socket

EXPERIMENTAL

8 immediately placed implants in which the socket defect will be treated utilizing vestibular socket therapy technique using cortical lamina , allograft , bone tacks for fixation and custom healing abutment

Other: Group B : the vestibular socket therapy

Interventions

collagen membrane and allograft bone for labial plate augmentation simultaneously with immediate implants placements in maxillary anterior region in the defected type 2 socket , custom healing abutment for soft tissue preservation in ice cream cone group

Group A :immediate dental Implants cases with ice-cream cone technique in type 2 socket

cortical lamina fixed by bone tacks and allograft bone for labial plate augmentation simultaneously with immediate implants placements in maxillary anterior region in the defected type 2 socket , custom healing abutment for soft tissue preservation in ice cream cone group

Group B : immediate dental Implants cases with the vestibular socket therapy in type 2 socket

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age more than 18 - 40 years.
  • Patients with missing single tooth or teeth in the esthetic zone.
  • Patients with buccal wall defect Type 2 A, B sockets (thin labial plate of bone less than 0.5 mm, presence of dehiscence or fenestration).
  • Good oral hygiene.
  • Patients willing to be present during the study follow-up intervals.
  • Patients free from any systemic diseases that may contraindicate implant placement .
  • Crown height space of at least 8 mm.
  • Patients without any para-functional habits (bruxism and clenching).

You may not qualify if:

  • Smoking people.
  • Alcohol or drug abuse.
  • Pregnancy.
  • Patients with poor oral hygiene or progressive periodontal disease .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Mansoura University

Al Mansurah, 7650001, Egypt

Location

Related Publications (5)

  • Sarnachiaro GO, Chu SJ, Sarnachiaro E, Gotta SL, Tarnow DP. Immediate Implant Placement into Extraction Sockets with Labial Plate Dehiscence Defects: A Clinical Case Series. Clin Implant Dent Relat Res. 2016 Aug;18(4):821-9. doi: 10.1111/cid.12347. Epub 2015 Apr 27.

    PMID: 25916859BACKGROUND
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    BACKGROUND
  • Th Elaskary A, Gaweesh YY, El Tantawi M, Maebed MA. Vestibular Socket Therapy: A Novel Approach for Implant Placement in Defective Fresh Extraction Sockets With or Without Active Socket Infection (One-Arm Cohort Study). Int J Oral Maxillofac Implants. 2021 Jan-Feb;36(1):146-153. doi: 10.11607/jomi.8732.

    PMID: 33600536BACKGROUND
  • Ghallab NA, Elaskary A, Elsabagh H, Toukhy AE, Abdelrahman H, El-Kimary G. A novel atraumatic extraction technique using vestibular socket therapy for immediate implant placement: a randomized controlled clinical trial. Oral Maxillofac Surg. 2023 Sep;27(3):497-505. doi: 10.1007/s10006-022-01089-4. Epub 2022 Jun 20.

    PMID: 35718834BACKGROUND
  • Elaskary A, Meabed M, Abd-ElWahab Radi I. Vestibular socket therapy with immediate implant placement for managing compromised fresh extraction sockets: A prospective single-arm clinical study. Int J Oral Implantol (Berl). 2021 Aug 20;14(3):307-320.

    PMID: 34415130BACKGROUND

Related Links

MeSH Terms

Conditions

Anodontia

Condition Hierarchy (Ancestors)

Tooth AbnormalitiesStomatognathic System AbnormalitiesStomatognathic DiseasesTooth DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 24, 2024

Study Start

April 21, 2024

Primary Completion

March 1, 2025

Study Completion

April 1, 2025

Last Updated

April 24, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations